Willebrand International Non-interventional Global Surveillance
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|ClinicalTrials.gov Identifier: NCT01949220|
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : August 8, 2018
|Condition or disease|
|Von Willebrand Disease|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Von Willebrand factor deficient patient
Inherited von Willebrand disease
- Documentation of product consumption data [ Time Frame: at each follow-up visit, up to 24 months ]Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations.
- Collection and analysis of adverse events and VWF immunological safety [ Time Frame: at each follow-up visit, up to 24 months ]Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949220
|Study Director:||Wolfgang MIESBACH, Dr||Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)|
|Study Director:||Flora PEYVANDI, Prof.||Faculty of Medicine, University of Milan, 20122 Milan (Italy)|